Novartis Replaces Japan Unit Head Amid Clinical Trial Probe

Novartis AG named Dirk Kosche as head of its Japan business, replacing Yoshiyasu Ninomiya after investigations showed that the unit involved itself in drug studies that were supposed to be independent of the company.

Novartis needs to rebuild a Japanese business that meets “legal obligations and executes operations ethically” under new management, the Basel, Switzerland-based drugmaker’s Japanese unit said in a statement today.

An investigation by a third-party commission appointed by the company disclosed yesterday that Novartis employees destroyed evidence and may have obtained patients’ personal information during a doctor-led leukemia study. Novartis has faced a string of other difficulties in Japan, including improper involvement in independent studies on hypertension drug Diovan and cancer treatment Tasigna.

Kosche has been with Novartis since 2001 as head of group strategic planning, the company said. Novartis also appointed Francis Bouchard to be head of oncology in Japan and Michael Ferris to lead a holding company, replacing Kazuo Asakawa and Hiroko Ishikawa. Asakawa retired, while Ninomiya and Ishikawa resigned, Novartis said.

Novartis is having its activities since 2011 reviewed by a third party to search for similar problems and will temporarily suspend supporting independent studies, it said. The review will be completed by summer this year and the company will report the results, it said.

‘Critical Problems’

An independent trial that found that Diovan, Novartis’ second-best selling medicine with $3.5 billion in sales in 2013, cut stroke risks in Japanese people, was retracted by the European Heart Journal in February last year because “critical problems existed with some of the data reported” in the paper. The data could have been manipulated, according to a report by the university that led the study.

The Lancet journal retracted another Japan study on Diovan in September saying “we no longer have confidence in the published results.”

Novartis Japan said in July it failed to disclose the ties of its employees in five such Diovan studies conducted between 2001 and 2004 in Japan. The scope of Novartis’s probe into the research, and whether it was falsified is limited because Novartis doesn’t have access to raw data of the studies, Ninomiya said at that time.

Japan’s health ministry filed a complaint with Tokyo prosecutors against Novartis in January, seeking a criminal investigation of the company for possibly breaching advertising rules with Diovan by exaggerating the medicine’s effectiveness in marketing materials.

Novartis Japan said in October it would set up an outside committee to advise on governance, tighten the process of funding trials and hold seminars internally for prevention. In January, Novartis Japan said its sales staff were involved in a doctor-led study using leukemia drug Tasigna and that it had hired a third party for investigation.

Such actions are “unacceptable and against the ethical standard set by Novartis” and the company will take measures against those employees, it said.

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